Outcomes measured but not analysed or reported and clinical judgement infers the presence of an unreported measured outcome.10

Other bias

No bias identified.

Bias identified. Unlikely to affect outcome.

Bias identified. Possible implication on outcome.

Bias identified. Likely to affect outcome.

Bias identified. Extremely likely to affect outcome.

1 Important confounders include patient specific factors (maternal age, parity, previous affected child, maternal IQ, socio-economic status, epilepsy type, seizure exposure, AED use and pre-intervention knowledge of AED and seizure-related pregnancy risks); resources/service specific factors (attendance rate of preconception counselling sessions).2 Reported demographic information and other confounders.3 Matching scores, multiple regression, analysis of co-variance, stratification.4 At least five out of ten of important confounders including maternal educational level or IQ, pre-intervention knowledge of AED and seizure related pregnancy risks and attendance of preconception counselling sessions.5 At least two out of ten of important confounders.6 Full adjustment of confounding variables e.g. see footnote 2, or partial adjustment e.g. researchers select limited number of variables to adjust for.7 Assessors of outcome are only blinded to certain groups e.g. blinded to intervention group but not controls.8 Intention-to-treat analysis.9 An a priori statement is made in methods section of main report regarding measurement and analysis of outcome.10 For example, failure to report full scale IQ when all other indices are reported.